FDA 510(k) Applications for Medical Device Product Code "DPS"
(Electrocardiograph)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K223013 | AccurKardia, Inc. | AccurECG Analysis System | 06/23/2023 |
| K152135 | ACME Portable Machines, Inc. | Quantitative Electrocardiographic Detector (QED 2000) | 08/09/2016 |
| K111805 | ADVANCED INSTRUMENTATIONS, INC. | ECG SERIES ELECTROCARDIOGRAPH | 08/24/2011 |
| K112135 | ADVANCED INSTRUMENTATIONS, INC. | ECG-6 SERIES ELECTROCARDIOGRAPH | 08/05/2011 |
| K002459 | AGILENT TECHNOLOGIES, INC. | PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH | 11/08/2000 |
| K972746 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100 | 10/21/1997 |
| K970787 | ALEXANDER MFG. CO. | ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3) | 05/14/1997 |
| K130409 | ALIVECOR, INC. | ALIVECOR HEART MONITOR | 09/06/2013 |
| K122356 | ALIVECOR, INC. | ALIVECOR HEART MONITOR FOR IPHONE | 11/19/2012 |
| K130921 | ALIVECOR, INC. | ALIVECOR HEART MONITOR OTC | 02/06/2014 |
| K110328 | ANDON HEALTH CO.,LTD | ACG-8511 PORTABLE ECG MONITOR | 07/15/2011 |
| K160667 | Anybattery, Inc. | Anybattery C2 Rechargeable Battery | 05/11/2017 |
| K972996 | ATES MEDICAL S.R.L. | EASY ECG PC BASED ELECTROCARDIOGRAPH | 04/28/1998 |
| K200884 | B-Secur Ltd. | B-Secur HeartKey Software Library | 12/07/2020 |
| K011177 | BCI, INC. | BCI ADVISOR VITAL SIGNS MONITOR (9200) | 05/23/2001 |
| K112622 | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. | HANDHELD ECG MONITOR | 07/19/2012 |
| K093872 | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. | HANDHELD ECG MONITOR, MODEL MD100 | 03/31/2010 |
| K080933 | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. | HANDHELD ECG MONITOR, MODEL MD100 | 09/26/2008 |
| K171517 | Biocare Bio-Medical Equipment Co., Ltd. | Digital Electrocardiograph | 01/11/2018 |
| K121825 | BIOMAGNETIK-PARK GMBH | CS-MAG II | 03/11/2013 |
| K113306 | BIONET CO., LTD. | CARDIO 7 | 07/16/2012 |
| K102767 | BIONET CO., LTD. | CARDIO XP | 06/03/2011 |
| K220535 | Bionet Co., Ltd. | Cardio10 | 11/15/2022 |
| K960449 | BIOSENSOR CORP. | PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) | 05/30/1996 |
| K974079 | BIOSOUND ESAOTE, INC. | FORMULA FOR ARCHIMED | 01/22/1998 |
| K083715 | BONUS COMMUNICACIONES SRL | BELTBEAT WF-400 | 09/15/2009 |
| K010955 | BOSTON MEDICAL TECHNOLOGIES, INC. | BMT ANSCORE HEALTH MANAGEMENT SYSTEM | 04/26/2001 |
| K993875 | BOSTON MEDICAL TECHNOLOGIES, INC. | BMT ANSCORE HEALTH MANAGEMENT SYSTEM | 08/11/2000 |
| K991831 | BOSTON MEDICAL TECHNOLOGIES, INC. | BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1 | 06/11/1999 |
| K013717 | BRENTWOOD MEDICAL TECHNOLOGY CORP. | BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY | 02/06/2002 |
| K052898 | BRENTWOOD MEDICAL TECHNOLOGY CORP. | IQMARK EZ STRESS | 03/28/2006 |
| K103640 | BRENTWOOD MEDICAL TECHNOLOGY CORP. | MIDMARK IQECG | 03/22/2011 |
| K010505 | BRENTWOOD MEDICAL TECHNOLOGY CORP. | TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY | 03/09/2001 |
| K140020 | BSP-BIIOLOGICAL SIGNAL PROCESSING, LTD. | HYPERQ ACS-100 SYSTEM | 10/28/2014 |
| K220362 | CAF Medical Solutions Inc. | LE-12CH | 03/25/2022 |
| K101016 | CAIRD TECHNOLOGY | ANS SYSTEM | 01/28/2011 |
| K012686 | CAIRD TECHNOLOGY | CAIRD TECHNOLOGY HOLTER 2000 | 12/13/2001 |
| K981697 | CAMBRIDGE HEART, INC. | CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM | 10/14/1998 |
| K950018 | CAMBRIDGE HEART, INC. | CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM | 02/29/1996 |
| K013565 | CAMBRIDGE HEART, INC. | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 | 11/21/2001 |
| K022149 | CAMBRIDGE HEART, INC. | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 | 07/16/2002 |
| K010758 | CAMBRIDGE HEART, INC. | HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS | 04/12/2001 |
| K022152 | CAMBRIDGE HEART, INC. | HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS | 07/16/2002 |
| K001034 | CAMBRIDGE HEART, INC. | MODEL APS ALTERNANS PROCESSING SYSTEM | 06/09/2000 |
| K013564 | CAMBRIDGE HEART, INC. | MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS | 11/21/2001 |
| K123217 | CARDEA ASSOCIATES INC | CARDEASCREEN | 02/05/2013 |
| K060167 | CARDIAC SCIENCE CORPORATION | ATRIA 3100, ATRIA 6100 | 04/19/2006 |
| K093211 | CARDIAC SCIENCE CORPORATION | CARECENTER MD | 06/03/2010 |
| K082173 | CARDIAC SCIENCE CORPORATION | Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S | 08/26/2008 |
| K221260 | CardiacSense | CSF-3 | 01/06/2023 |
| K121009 | CARDIO COMM SOLUTIONS, INC. | HEARTCHECK ECG PEN WITH GEMS HOME | 05/17/2012 |
| K111159 | CARDIO COMM SOLUTIONS, INC. | HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME | 12/22/2011 |
| K143432 | CARDIO-PHOENIX INC. | Cardio-TriTest | 06/03/2015 |
| K182790 | Cardio-Phoenix Inc. | Cardio-TriTest v6.5 | 12/14/2018 |
| K020366 | CARDIOCOMM SOLUTIONS, INC. | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) | 04/30/2002 |
| K122632 | CARDIOCOMM SOLUTIONS, INC. | GUAVA II | 02/11/2014 |
| K160746 | CARDIOLINE S.p.A | CARDIOLINE touchECG | 11/02/2016 |
| K160840 | CARDIOLINE S.p.A | ECG100+, ECG200+ | 08/12/2016 |
| K170568 | Cardiologs Technologies | CardioLogs ECG Analysis Platform | 06/26/2017 |
| K212112 | Cardiologs Technologies | Cardiologs Holter Platform | 11/18/2021 |
| K002197 | CARDIONICS, INC. | CARTOUCH | 12/27/2000 |
| K052295 | CARDIOSOFT, L.P. | CARDIOSOFT PC ECG, USB VERSION | 01/13/2006 |
| K033488 | CMI CARDIOMAG IMAGING INC | CMI MAGNETOCARDIOGRAPH | 07/07/2004 |
| K212163 | Coala Life AB | Coala Heart Monitor | 04/14/2022 |
| K050674 | COMMWELL LTD. | PHYSIOGLOVE ES | 04/25/2006 |
| K103791 | COMMWELL LTD. | PHYSIOGLOVE ES WITH ECG ANALYSIS | 10/21/2011 |
| K131900 | CONTEC MEDICAL SYSTEM CO., LTD. | CONTEC ELECTROCARDIOGRAPH | 03/05/2014 |
| K090936 | CONTEC MEDICAL SYSTEM CO., LTD. | SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A | 08/25/2009 |
| K152863 | CONTEC MEDICAL SYSTEMS CO., LTD | Portable ECG Monitor | 06/22/2016 |
| K171360 | Contec Medical Systems Co., LTD. | CONTECÖ Electrocardiograph | 01/22/2018 |
| K170954 | CONTEC Medical Systems Co.,Ltd | Portable ECG Monitor | 05/30/2017 |
| K183369 | Corscience GmbH & Co. | COR12 ECG | 12/28/2018 |
| K014262 | COSMED S.R.L. | COSMED QUARK C12/QUARK T12 | 03/26/2002 |
| K170154 | Creavo Medical Technologies, Ltd. | Creavo Vitalscan Magnetocardiograph | 10/12/2017 |
| K973426 | D. E. HOKANSON, INC. | ANS 2000 ECG MONITOR AND RESPIRATION PACER | 08/12/1998 |
| K062894 | DAILYCARE BIOMEDICAL INC | INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 | 02/08/2007 |
| K042814 | DAILYCARE BIOMEDICAL INC | READMYHEART | 01/06/2005 |
| K052303 | DAILYCARE BIOMEDICAL INC | READMYHEART, MODEL RMH2.0 | 12/16/2005 |
| K050620 | DAILYCARE BIOMEDICAL INC | READMYHEART, MODEL RMH3.0 | 07/14/2005 |
| K172778 | DailyCare Biomedical, Inc | CheckMyHeart Plus | 07/05/2018 |
| K011436 | DATA CRITICAL CORPORATION | MOBILE-PATIENT VIEWER | 07/05/2001 |
| K961247 | DATEX DIVISION INSTRUMENTARIUM CORP. | AS/3 LIGHT MONITOR | 10/23/1996 |
| K980362 | DATEX-ENGSTROM, INC. | MRI COMPATIBLE MONITOR AND ACCESSORIES | 06/30/1998 |
| K053083 | DATRIX | DATRIX CARDIO WIFI ELECTROCARDIOGRAPH | 11/30/2005 |
| K040313 | DEL MAR REYNOLDS MEDICAL, LTD. | HRV TOOLS | 04/06/2004 |
| K062469 | DEL MAR REYNOLDS MEDICAL, LTD. | VOYAGER 12 | 11/03/2006 |
| K131572 | DIMETEK DIGITAL MEDICAL TECHNOLOGIES LTD | MICRO AMBULATORY ECG RECORDER | 07/22/2013 |
| K972603 | DR. LEE CO., LTD. | ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B | 03/11/1998 |
| K072353 | DYANSYS CORP | PORTABLE ECSCOPE | 08/30/2007 |
| K091358 | DYANSYS, INC. | ECSCOPE 100 | 05/28/2009 |
| K091397 | DYANSYS, INC. | ECSCOPE 200 | 07/08/2009 |
| K080036 | DYANSYS, INC. | PORTABLE ECSCOPE 12I | 01/16/2008 |
| K071168 | DYANSYS, INC. | THE PORTABLE ANSISCOPE | 08/31/2007 |
| K093172 | DYNACARDIA, INC. | QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) | 01/20/2010 |
| K120188 | EDAN INSTRUMENTS INC | ELECTROCARDIOGRAPH | 03/16/2012 |
| K210140 | Edan Instruments, Inc | electrocardiograph: SE-1202 | 10/01/2021 |
| K170995 | Edan Instruments, Inc. | Electrocardiograph | 06/02/2017 |
| K212278 | Edan Instruments, Inc. | Electrocardiograph | 04/07/2022 |
| K171942 | Edan Instruments, Inc. | Electrocardiograph | 01/24/2018 |
| K171943 | Edan Instruments, Inc. | Electrocardiograph | 09/25/2017 |
| K102830 | EDAN INSTRUMENTS, INC. | ELECTROCARDIOGRAPH | 12/02/2010 |
| K222902 | Edan Instruments, Inc. | Electrocardiograph: SE-1200 Pro and SE-1201 Pro | 07/28/2023 |
| K160876 | EDAN INSTRUMENTS, INC. | PC ECG | 02/15/2017 |
| K152427 | EDAN INSTRUMENTS, INC. | PC ECG | 02/05/2016 |
| K161302 | EDAN INSTRUMENTS, INC. | PC ECG | 07/01/2016 |
| K131819 | EDAN INSTRUMENTS, INC. | PC ECG | 11/22/2013 |
| K102854 | EDAN INSTRUMENTS, INC. | PC ECG | 12/03/2010 |
| K092010 | EDAN INSTRUMENTS, INC. | PC ECG, MODEL SE-1010 | 10/22/2009 |
| K090367 | EDAN INSTRUMENTS, INC. | SE-601 SERIES ELECTROCARDIOGRAPH | 06/03/2009 |
| K093869 | EDAN INSTRUMENTS, INC. | SE-601 SERIES ELECTROCARDIOGRAPH | 04/01/2010 |
| K131503 | EDAN INSTRUMENTS, INC. | SE-601 SERIES ELECTROCARDIOGRAPH | 02/25/2014 |
| K091513 | EDAN INSTRUMENTS, INC. | SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 | 07/24/2009 |
| K082380 | ENERGY-LAB TECHNOLOGIES GMBH | VICARDIO 12B | 12/03/2008 |
| K051534 | ET MEDICAL DEVICES SPA | CARDIOLINE AR 600, AR 1200, AR 2100 | 10/05/2005 |
| K082124 | ET MEDICAL DEVICES SPA | CARDITTE MICROTEL | 02/19/2009 |
| K173226 | Fukuda Denshi USA, Inc. | CardiMax Electrocardiograph | 04/16/2018 |
| K955416 | FUKUDA DENSHI USA, INC. | CARDIMAX MODEL FX-2111 | 07/15/1996 |
| K051163 | GALIX BIOMEDICAL INSTRUMENTATION, INC. | GALIX ECG PROFESSIONAL STATION | 01/31/2006 |
| K073625 | GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES | MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM | 01/25/2008 |
| K090212 | GE MEDICAL SYST. INFORMATION TECHNOLOGIES | MAC 800 RESTING ECG ANALYSIS SYSTEM | 02/19/2009 |
| K142288 | GE MEDICAL SYSTEMS CHINA CO., LTD. | MAC 800 Resting ECG Analysis System | 12/03/2014 |
| K081437 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MAC 1600 ECG ANALYSIS SYSTEM | 07/15/2008 |
| K042177 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM | 08/27/2004 |
| K120770 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | QT GUARD PLUS ANALYSIS SYSTEM | 12/06/2012 |
| K110266 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC | MAC 5500 HD, MAC 3500 | 04/29/2011 |
| K103765 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC | MAC 600 RESTING ECG ANALYSIS SYSTEM | 05/17/2011 |
| K221321 | GE Medical Systems Information Technologies, Inc. | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | 10/18/2022 |
| K203786 | GE Medical Systems Information Technologies, Inc. | MAC 7 - Resting ECG Analysis System | 04/30/2021 |
| K173830 | GE Medical Systems Information Technologies, Inc. | MAC VU360 Resting ECG Analysis System | 09/18/2018 |
| K092576 | GEM-MED S.L. | GEM HEART ONE/ONE+ | 09/04/2009 |
| K000645 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN | GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11 | 05/24/2000 |
| K991786 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN | MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION | 11/18/1999 |
| K182571 | Genetesis Inc. | CardioFlux with Faraday Analytical Cloud | 03/15/2019 |
| K131858 | GUANGDONG BIOLIGHT MEDITECH CO., LTD. | DIGITAL ELECTROCARDIOGRAPH | 06/11/2014 |
| K002074 | H&C MEDICAL DEVICES SPA | AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES | 10/04/2000 |
| K010822 | H&C MEDICAL DEVICES SPA | AB CARDIETTE START 200 HV | 04/18/2001 |
| K013615 | HARBINGER MEDICAL, INC. | MICRO-INDUCTION 1000 SYSTEM | 05/29/2002 |
| K090249 | HARBINGER MEDICAL, INC. | MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM | 04/03/2009 |
| K050858 | HEARTLAB, INC. | ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM | 06/29/2005 |
| K082312 | HEARTSCAPE TECHNOLOGIES LTD | PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) | 09/12/2008 |
| K950989 | HELLIGE GMBH | CARDIOSMART | 05/13/1996 |
| K961401 | HEWLETT-PACKARD CO. | HP CATHSTATION - MODEL M1264B | 10/08/1996 |
| K974746 | HEWLETT-PACKARD CO. | M1765A ECG MANAGER | 03/18/1998 |
| K973437 | HEWLETT-PACKARD GMBH | HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES | 12/03/1997 |
| K142551 | HHSsystems, LLC | QANS (Quantitative Autonomic Nervous System) Monitoring System | 04/16/2015 |
| K191692 | iMedrix Inc. (formerly Piitech Inc.) | KardioScreen | 01/10/2020 |
| K070136 | INOVISE MEDICAL, INC. | AUDICOR 200 SYSTEM, MODELS 200D AND 200S | 04/13/2007 |
| K032145 | INOVISE MEDICAL, INC. | AUDICOR UPGRADE SYSTEM | 10/31/2003 |
| K043074 | INOVISE MEDICAL, INC. | LIBERTY SYSTEM | 02/22/2005 |
| K964408 | INSTROMEDIX, INC. | POSEIDON CARDIAC MONITORING SYSTEM (PCMS) | 07/23/1997 |
| K062068 | INTELWAVE, LLC | INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 | 10/27/2006 |
| K963578 | INTL. PRODUCTS, INC. | PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) | 06/30/1997 |
| K143436 | InvisionHeart Inc. | InvisionECG System | 05/21/2015 |
| K955045 | INVIVO RESEARCH, INC. | OMNI-TRAK PATIENT MONITORING SYSTEM | 07/11/1996 |
| K955546 | IVY BIOMEDICAL SYSTEMS, INC. | PATIENT MONITOR MODEL 405P | 08/16/1996 |
| K955113 | JOHNSON & JOHNSON MEDICAL, INC. | DINAMAP SELECT MULTI-PARAMETER SYSTEM | 08/15/1996 |
| K971038 | KONTRON INSTRUMENTS LTD. | KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE | 09/24/1997 |
| K981951 | MACQUARIE MEDICAL SYSTEMS | CT 100 ELECTROCARDIOGRAPH | 07/28/1998 |
| K961798 | MACQUARIE MEDICAL SYSTEMS | CT 200 ELECTROCARDIOGRAPH | 08/05/1998 |
| K972199 | MARQUETTE ELECTRONICS, INC. | SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS | 09/25/1997 |
| K142969 | MDOLORIS MEDICAL SYSTEMS SAS | ANI Monitor | 02/23/2016 |
| K021230 | MEDICAL DECISION NETWORKS | HERO | 05/09/2003 |
| K082967 | MEDICAL POSITIONING, INC. | MORTARA STRESS ECHO BED | 03/26/2009 |
| K021171 | MEDICAL POSITIONING, INC. | Q-STRESS ECHO BED | 05/08/2002 |
| K002822 | MEDICAL POSITIONING, INC. | VERTEX SYSTEM | 01/31/2001 |
| K111601 | MEDICAL PREDICTIVE SCIENCE CORP. | HERO | 07/08/2011 |
| K081473 | MEDICAL PREDICTIVE SCIENCE CORP. | HERO, VERSION 2.0 | 06/27/2008 |
| K180242 | Medical Predictive Science Corporation | HeRO Symphony, HeRO ES, HeRO solo/duet | 02/28/2018 |
| K221141 | Medizin Systeme Boblingen GmbH | PageWriter TC35 Cardiograph | 12/02/2022 |
| K080884 | MEDTECHS, LLC | QHRV 1 - HEALTH ASSESSMENT SYSTEM | 04/11/2008 |
| K024278 | MEDTRONIC VASCULAR | PACEART SYSTEM | 05/29/2003 |
| K103427 | MEMTEC CORP. | MOBILEECG SYSTEM | 03/24/2011 |
| K103077 | MERIDIAN DYNAMICS BIOMEDICAL, INC | ECG PEN | 07/13/2011 |
| K012414 | MERIDIAN MEDICAL TECHNOLOGIES, INC. | PRIME ECG SYSTEM | 03/06/2002 |
| K030104 | MERIDIAN MEDICAL TECHNOLOGIES, INC. | PRIME ECG SYSTEM | 06/11/2003 |
| K223670 | MESI, Development of Medical Devices, Ltd; MESI, D.O.O. | MESI mTablet ECG Diagnostic System, MESI mTablet ECG | 07/28/2023 |
| K963198 | METRON U.S., INC. | PS-41 6M PATIENT SIMULATOR | 03/05/1997 |
| K012540 | MICROMEDICAL INDUSTRIES, LTD. | BLY-501 ADAPTOR | 09/26/2001 |
| K974351 | MICROMEDICAL, INC. | BIOLOG 3000 ELECTROCARDIOGRAPH | 04/01/1998 |
| K955891 | MICROMEDICAL, INC. | CARDIOVIEW TRANSTELEPHONIC SOFTWARE | 10/08/1996 |
| K974220 | MICROMEDICAL, INC. | MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE | 08/25/1998 |
| K162665 | MITAC INTERNATIONAL CORP. | MiCor A100 Wearable ECG Recorder | 01/26/2018 |
| K113234 | MOBHEALTH INCORPORATION | MOBCARDIO SYSTEM | 11/17/2011 |
| K062282 | MONEBO TECHNOLOGIES, INC. | MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0 | 03/22/2007 |
| K043380 | MONEBO TECHNOLOGIES, INC. | MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1 | 04/26/2005 |
| K101115 | MORTARA INSTRUMENT, INC | ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 | 06/18/2010 |
| K142105 | MORTARA INSTRUMENT, INC | ELI 380 ELECTROCARDIOGRAPH | 09/05/2014 |
| K120865 | MORTARA INSTRUMENT, INC | RSCRIBE ELECTROCARDIOGRAPH | 07/19/2012 |
| K102206 | MORTARA INSTRUMENT, INC. | ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 | 02/18/2011 |
| K031182 | MORTARA INSTRUMENT, INC. | ELI 200+ AUDICOR | 07/25/2003 |
| K100127 | MORTARA INSTRUMENT, INC. | ELI 230 ELECTROCARDIOGRAPH | 04/16/2010 |
| K101403 | MORTARA INSTRUMENT, INC. | ELI 250 ELECTROCARDIOGRAPH | 07/02/2010 |
| K122073 | MORTARA INSTRUMENT, INC. | ELI 280 ELECTROCARDIOGRAPH | 08/02/2012 |
| K062677 | MORTARA INSTRUMENT, INC. | ELI 350 ELECTROCARDIOGRAPH | 11/15/2006 |
| K092663 | MORTARA INSTRUMENT, INC. | ELI 350 ELECTROCARDIOGRAPH | 12/14/2009 |
| K093339 | MORTARA INSTRUMENT, INC. | ELI PC ELECTROCARDIOGRAPH | 02/19/2010 |
| K070539 | MORTARA INSTRUMENT, INC. | MORTARA ELI 10 ELECTROCARDIOGRAPH | 03/15/2007 |
| K082946 | MORTARA INSTRUMENT, INC. | MORTARA ELI 350 ELECTROCARDIOGRAPH | 12/29/2008 |
| K022618 | MORTARA INSTRUMENT, INC. | X-SCRIBE II | 09/06/2002 |
| K152944 | MORTARA INSTRUMENT, INC. | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems | 01/06/2016 |
| K012263 | NATIONAL CUSTOM ENT., INC. | MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 | 10/10/2001 |
| K012264 | NATIONAL CUSTOM ENT., INC. | MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC | 10/10/2001 |
| K955642 | NELLCOR PURITAN BENNETT, INC. | NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER | 07/02/1996 |
| K963400 | NELLCOR PURITAN BENNETT, INC. | NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER | 11/26/1996 |
| K052511 | NIHON KOHDEN AMERICA, INC. | CARDIOFAX CE, MODEL ECG-1500 A | 05/24/2006 |
| K042827 | NIHON KOHDEN AMERICA, INC. | CARDIOFAX CE, MODEL PEA-1110K | 01/06/2005 |
| K072217 | NIHON KOHDEN AMERICA, INC. | ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M | 08/30/2007 |
| K972310 | NIHON KOHDEN AMERICA, INC. | NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH | 08/20/1997 |
| K072060 | NIHON KOHDEN AMERICA, INC. | QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V | 08/17/2007 |
| K002473 | NIHON KOHDEN AMERICA, INC. | WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES | 11/08/2000 |
| K060766 | OMRON HEALTHCARE, INC. | PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 | 06/09/2006 |
| K951128 | OXFORD MEDICAL, INC. | MEDILOG STRESSLINK | 08/28/1996 |
| K061123 | PARAMA-TECH COMPANY., LTD | PALM ECG RECORDER, MODEL EP-201/202 | 06/29/2007 |
| K112959 | PHILIPS HEALTHCARE | CALG-STR EXERCISE ECG ANALYSIS ALGORITHM | 01/26/2012 |
| K210560 | Philips Medical Systems | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph | 06/30/2021 |
| K080999 | PHILIPS MEDICAL SYSTEMS | PAGEWRITER CARDIOGRAPH | 05/09/2008 |
| K113144 | PHILIPS MEDICAL SYSTEMS | PAGEWRITER TC 20, 30, 50, 70 | 04/03/2012 |
| K191738 | Philips Medical Systems | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph | 09/29/2020 |
| K052049 | PHILIPS MEDICAL SYSTEMS | PHILIPS 12-LEAD ALGORITHM | 08/26/2005 |
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